a phase 3, randomized, double-blind, placebo-controlled study for subjects with locally-advanced unresectable or metastatic synovial sarcoma (v943-003, imdz-04-1702)

Conditions: Synovial Sarcoma; Cancer; Soft Tissue Sarcoma; Sarcoma; Metastatic Sarcoma

Summary: to assess if the cmb305 vaccine regimen may help the body's immune system to slow or stop the growth of synovial sarcoma tumor and improve survival.

the synovate study is a global, randomized, double-blind, placebo-controlled, phase 3 study in patients with unresectable, locally-advanced or metastatic new york esophageal squamous cell carcinoma 1 (ny-eso-1) positive synovial sarcoma following first-line systemic anti-cancer therapy.

Eligibility criteria:
selected inclusion criteria: * histological diagnosis of synovial sarcoma * immunohistochemistry (ihc) results from tumor biopsy for new york esophageal squamous cell carcinoma 1 (ny-eso-1) are positive * participants have received at least 4 but no more than 8 cycles of first-line anthracycline or ifosfamide-containing systemic anti-cancer therapy regimen * must have documentation of no evidence of disease progression of the tumor during or after completion of first line systemic anti-cancer therapy * ecog (eastern cooperative oncology group) performance status of 0 or 1 * age \>/= 12 years * life expectancy of at least 6 months selected exclusion criteria: * have received last dose of first-line systemic anti-cancer therapy or date of most recent local regional therapy \>28 days prior to day 1 * have received prior anti-ny-eso-1 therapy * have received first-line systemic anti-cancer therapy with an agent other than anthracycline or ifosfamide * have received treatment with systemic immunomodulatory agents within 28 days prior to administration of the first dose of cmb305, or 5 half-lives of the drug, whichever occurs sooner. * have significant immunosuppression from concurrent, recent, or anticipated need for chronic treatment with systemic immunosuppressive dose of corticosteroids or immunosuppressive medications. * have psychiatric or other medical illness, or any other condition that in the opinion of the investigator prevents compliance with the study procedures or ability to provide valid informed consent. * have history of uncontrolled autoimmune disease. * have a significant electrocardiogram finding or cardiovascular disease * have inadequate organ function per protocol * history of other cancer within 3 years * evidence of active tuberculosis or recent clinically-significant infection requiring systemic therapy. * evidence of active hepatitis b, hepatitis c, or human immunodeficiency virus (hiv) infection * have a history of brain metastasis * have received cancer therapies including chemotherapy, radiation, biologic, or kinase inhibitors, granulocyte-colony stimulating factor (g-csf), or granulocyte-macrophage colony-stimulating factor (gm-csf) within 3 weeks prior ot the first scheduled dose of cmb305 * female of child bearing potential who is pregnant, is planning to become pregnant, or is breast feeding; or male who is sexually active with a female of child bearing potential who is planning to become pregnant.

Keywords: synovate study ny-eso-1 cancer vaccine sarcoma soft tissue sarcoma immunotherapy